1. Field of Invention
The present invention relates to a tissue suturing system for suturing tissues in the body by using an endoscope, and more specifically, to a tissue suturing system combined with a flexible endoscope for enabling the formation of an artificial valve to treat gastroesophageal reflux disease (GERD).
2. Description of the Related Art Statement
Currently, in many cases, in-vivo tissue of a patient is sutured through surgical operation. A surgical operation, however, is highly invasive because it naturally requires an incision to the patient's body. Furthermore, it requires post-operative hospitalization, the cost of which can be a heavy burden for the patient. In these circumstances., the development of a low-invasive oral endoscopic procedure that eliminates the need for open surgery is anticipated.
The incidence of GERD has increased recently. The main symptoms of GERD are heartburn and mucosal breaks in the esophagus. Although it is a benign disease, GERD is accompanied by serious pain and often requires treatment. The main cause of GERD is decreased function of the lower esophageal sphincter (LES) at the bottom of the esophagus followed by reflux of acid into the esophagus. GERD is usually treated by administration of acid secretion controlling agent such as proton-pump inhibitor. Moderate GERD will improve and may be treated completely by medication. If, however, the LES function is damaged seriously or if anatomic. problems such as hiatal hernias exist, treatment with medication is less effective, and becomes costly over an extended period of time
Therefore, cases of serious GERD are often treated surgically. Effective surgical methods-including Nissen fundoplication or Toupet method are known and applied widely. With this method, the LES is wrapped by the stomach wall to improve its function. This method has been proven highly effective. Recently, laparoscopic surgery techniques were used with this method as a less invasive treatment. Because there are many patients, and GERD is a benign disease, these less invasive treatments are most desirable. One such technique involves the formation of an artificial valve to prevent the reflux of acid.
For example, there is an instrument for suturing in-vivo tissue through an oral endoscopic, the composition of which has been disclosed in the U.S. Pat. No. 5,792,153 as shown in FIG. 99 through FIG. 103. The instrument (a) which can be mounted on an endoscope, comprises a tube (b) that can be connected to the suction source, a cavity (c) to which the tube (b) is joined, a hollow needle (d) inserted in the forceps channel of the endoscope, a tag (g) provided with a lumen and side holes (e and f) that can be incorporated into the needle, a wire (i) with a valve (h) which can move back and forth in the needle (d) and can be mounted to the side hole (e) detachably by a thread (j) tied to the tag (g), and a grasping member (k) which is provided at the tip of the cavity (c) and is easily connected and disconnected to the side hole (f).
With the valve (h) joined to the side hole (e), the tag (g) is inserted into the needle (d). Then, an endoscope, with the instrument (a) mounted on it, is orally inserted into the patient's lumen to suck the tissue (l) to be sutured into the cavity (c). The tissue (l) is then penetrated with the needle (d) that has been thrust out through the endoscope tip. Next, the wire (i) is pushed forward to thrust out the tag (g) through the needle (d) so that the side hole (f) of the tag (g) can be joined to the grasping member (k). The valve (h) is then removed from the side hole (e) so as to pull the wire (i) and the needle (d) into the endoscope. After this, suction is released.
Again, the tissue (l) is sucked into the cavity (c) to be penetrated with the needle (d). Then the valve (h) is joined to the side hole (e) and the grasping member (k) is removed from the opening (f). The valve (h), the tag (g) and the needle (d) are withdrawn and the suction is released. The steps above are repeated as many times as are necessary and then the instrument (a) is removed from the lumen together with the endoscope. When both ends of the thread, which have been pulled out from the body, are tied together and fixed, the suture procedure is terminated. Since the distal end of the endoscope is attached above the instrument, and the cavity is fixed in the vicinity of the distal end of the endoscope in the construction disclosed in U.S. Pat. No. 5,792,153, it is difficult to observe the tissue sucked into the cavity. As the needle cannot be confirmed to have penetrated the desired puncture site before the needle actually punctures the tissue sucked into the cavity, accurate control of the puncture site is extremely difficult. As a result, accurate suturing cannot be achieved, or more stitches are required, thus increasing the treatment time.
Moreover, inability to control the intervals between the stitches will prevent the tissue from being securely sutured with less number of stitches.
In addition, each penetration requires joining the valve (h) and the side hole (e) and releasing the grasping member (k) and the opening (f) and vice versa.
These two operations, required per penetration, will make the treatment procedure very complicated, extending the treatment time as well.
Although the puncture range in a single puncture depends on the size of the cavity, the outer diameter of the entire instrument must inevitably be limited to ease the burden on the patient during insertion. Since the endoscope and the cavity are not aligned in this construction, the size of the cavity must inevitably be limited. If the suture range is larger than the range sucked into the cavity, suturing itself becomes impossible, thus limiting its applicability.